Wednesday, May 4, 2011

ACCME Seeks to Hide Drug Company Disclosures in the Fine Print

In an absolutely perplexing move, Dr. Murray Kopelow and the ACCME are proposing a revision to their Standards for Commercial Support that will undermine those standards. Currently, when an education company solicits money from industry to underwrite a course for doctors, they must disclose this inherent conflict of interest, and they often do so by printing the company's logo somewhere.

This tells you that the course is likely to biased in favor of a Lilly product, and that you should hightail your way to a different website. But since it is offering you 20 free CME credits, you might be tempted to take the course. If you do, you will at least know that you should evaluate the content very carefully for bias.

Of course, simply displaying the supporter's name is hardly full disclosure. In my opinion, the supporter should be required to provide more information, including:

--The name of the product(s) marketed by the supporter that might be relevant to depression (in this case, Cymbalta and Symbyax.) Disclosing this is crucial, because many doctors do not know exactly which products a particular company markets, and therefore may not realize how the company has a financial stake in the CME program.

--The amount of money the supporter has paid the educational company to create the CME course. The more money that is at stake, the larger is the incentive for a company to bias the program in favor of the supporter's drug. Did Lilly pay Medscape $100,000 or $1,000,000 for this course? If it was $1,000,000 (and I'm guessing this figure is closer to the true amount), a learner would reasonably become even more skeptical about the scientific validity of the course.

But instead of increasing disclosure, ACCME is proposing a decrease in disclosure. They are, quite literally, proposing that all disclosures get buried in the fine print.

“The provider’s acknowledgment of commercial support as required by SCS 6.3 and 6.4 under Standard 6 of the ACCME Standards for Commercial Support must only state the name of the company supplying the commercial support, in text format only. Disclosure cannot contain corporate logos and cannot mention or describe any other units within the commercial interest’s corporate structure.”

I assume that ACCME's motivations are pure--apparently it believes that it has already succeeded in scrubbing all commercial bias from CME courses, and that there is one loose end to tie up, which is getting rid of company logos. But the organization has deluded itself. In fact, commercial bias continues to be rampant throughout the CME world, and this proposal will be a great gift to drug companies and their education company sidekicks.

Any MBA will tell you that the best marketing uses advertising that doesn't look like advertising. That way, the customer does not realize that there is a hidden agenda. Commercial CME already is advertising disguised as medical education--this new proposal will make that disguise even more impenetrable.

8 comments:

I am with you on this point of view. The CME world needs more prominent disclosure, not less. Somebody has to connect the dots for the average busy MDs who are conditioned to trust what they see in educational programs.

Message shaping may be more overt but it's still there. I suppose Big Pharma will accept half a loaf in how they game CME content.

I mentioned in a comment to an earlier posting that Dr. Donald Goldenberg, (a Lilly plant) implicitly pumped Cymbalta in a Fibromyalgia CME by doing a beat down on Lyrica in a head to head slide. Very clever.

In Dr. Carlat's "Performance Improvement" CME posting, the presenter Dr. Larry Culpepper, (another Lilly plant) explicitly included the claim on a slide that SNRI's are more effective for "melancholic depression".

Has that claim been clinically demonstrated? Can the average GP even discriminate melancholic depression from another sub-type? I'm guessing from their limited diagnostic PoV, every patient who is depressed is melancholic in some way.

And which SNRI is pumped up in the media that plants the SNRI brand seed in the physician's mind? Why Cymbalta of course.

"In response to provider feedback and to strengthen the firewall between accredited continuing medical education and promotion, the ACCME is proposing a change in policy to prohibit the use of corporate logos or the mention of corporate divisions in commercial support disclosure statements."

Which is the lesser evil? To "hide disclosures in the fine print," or to give companies free ad space to display their attractive corporate logo and a comforting tag line about making the world a better place? Dan, you apparently prefer the latter. Personally, I'm really not sure.

On a related note, disclosure itself is revered as some sort of cure for bias, which it certainly isn't. On the contrary, research suggests that disclosure may invite more bias into presentations, and lull listeners into a false sense of security. I recently wrote about that here.

The issues, political and psychological, are complex. Even well-intentioned, likeminded people can disagree about tactics.

Steve, I agree with you--there are different ways to approach the problem of commercial bias. In this particular case I think ACCME is misguided. And while I do believe they are sincerely trying to get commercial bias out of CME, I also believe they are in the thrall of the industry that they are regulating, as many other regulatory agencies are.

For years now, certainly since the vaunted 2004 updated Standards for Commercial Support, the ACCME has argued that they have created an effective firewall to prevent commercial bias. But any physician with an ounce of informed skepticism knows that the majority of supported CME offerings continue to be highly biased, though the bias has become more subtle and hidden from plain view. This latest proposal does nothing to address the underlying problem, and in my view will aggravate it.

Dan, I agree that "the majority of supported CME offerings continue to be highly biased, though the bias has become more subtle and hidden from plain view." Short of prohibiting corporate sponsorship entirely, it's truly hard to neutralize the dedicated efforts of monied interests. Perhaps additional disclosures, as suggested in your post, would help. Or warnings akin to those on cigarette packs — "Caution: Corporate sponsorship has been associated with hidden promotional content and biased educational material."

Frankly, I'm skeptical any such warnings or disclosures will have much effect. Consumer goods, from expensive cars to cheap fast food, are sold using ads with clear disclosure of corporate sponsorship and an obvious sales motive. If these don't hurt sales, I don't see how the big red Lilly logo on the Medscape site will either. Logos are carefully designed for positive vibes.

I submitted a comment to ACCME favoring their proposal to ban logos, and I suggested they ban corporate slogans and tag-lines as well. These are all promotional in nature. But I added that they should require plain-font disclosure in large prominent type, so as not to bury the disclosure in fine print — despite the research I mentioned that even this may not be helpful.

Until corporate sponsorship of CME is banned completely, we're relegated to playing this game of nip and tuck. Thrall or not, regulatory bodies like ACCME are not equipped to regulate subtle persuasion and psychological nuance.

I think that in the course of all this hand wringing about conflict of interest and pharmaceutical profits, we should all remember that 10% of national healthcare expenditures are going to drugs.

The other 90% are passing through organizations that are owned or managed by MDs, who daily make decisions in which there is a profound conflict of interest between personal financial interests on one hand and those of patients and society on the other.

There is no other industry in the US where workers who decide which procedures are needed are also paid by the number and type of procedures performed. We can all stand around and wring our hands over the dripping faucet, but the fact remains that we have a broken water main in the front yard.